Purpose

Light-induced fluorescence was evaluated as a process analytical tool in the development of quantitative models for the monitoring of a low-dose formulation manufacturing process.

Method

The system, equipped with a probe, was positioned in a tablet press feed-frame to monitor the active pharmaceutical ingredient content of the flowing powder before compression.

Results

Modeling errors of 1.1% and lower in cross-validation for a 0.67% w/w drug load were observed, which is remarkable for a process analytical tool.

Conclusions

While light-induced fluorescence is emerging as a promising technology, robustness improvements and demonstration of method validation are still required. The technology is expected to become a tool of choice, ready for manufacturing deployment, to support the monitoring and potentially control of low-dose pharmaceutical formulations.

中文翻译：

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使用光诱导荧光光谱法进行低剂量制剂监测和控制的可行性

目的

在定量模型开发中，将光诱导的荧光作为过程分析工具进行评估，以监测低剂量制剂的生产过程。

方法

将装有探针的系统置于压片机的进料架中，以监测压制前流动粉末中活性药物成分的含量。

结果

对于0.67％w / w的载药量，发现交叉验证中的建模误差为1.1％或更低，这对于过程分析工具而言是非常显着的。

结论

尽管光诱导荧光正在成为一种有前途的技术，但仍需要改进鲁棒性和方法验证的证明。预计该技术将成为选择的工具，准备用于生产部署，以支持对低剂量药物制剂的监视和潜在控制。